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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles. GLP.
Justification for type of information:
Read across justification included in Section 13
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles. GLP.
Justification for type of information:
Read across justification included in Section 13
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure, occlusive wrap
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: non-abraded and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
Observations were made and 24 and 72 hours and at 7 and 14 days after treatment.
Number of animals:
6 animals
Details on study design:
Observations were not made at 48 hours. Therefore, the mean erythema and mean edema scores do not reflect a 24, 48, and 72 hour average, rather they reflect a 24 and 72 hour average.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 72 hrs
Score:
ca. 0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not Specified
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24 hrs
Score:
ca. 0.5
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 72 hrs
Score:
ca. 0.5
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 7 days
Score:
ca. 0.92
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
24/72 hr time point average
Time point:
other: 24/72 hr
Score:
ca. 0.5
Max. score:
0.5
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not Specified
Other effects:
Unleaded motor gasoline was administered via an occlusive dermal patch on abraded skin. The erythema scores at 24 and 72 hours and at 7 and 14 days were 0.0, 1.0, 0.17, and 0.0, respectively. Erythema was fully reversible within 14 days after treatment. The edema scores at 24 and 72 hours and at 7 and 14 days were 0.5, 0.5, 1.08, and 0.0, respectively. Edema was fully reversible within 14 days after treatment.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results of this study cannot be directly interpreted for classification of skin irritation due to deviations from the EEC regulatory protocol, consisting of the use of a 24 hr, rather than a 4 hr, exposure period and the use of an occlusive, rather than a semi-occlusive, wrap.
Executive summary:

Unleaded motor gasoline (API PS-6) was administered via occlusive dermal patch on non-abraded and abraded skin of 6 New Zealand White rabbits at doses of 0.5 ml for 24 hours to assess dermal irritation. Clinical observations were made at 24 and 72 hours and at 7 and 14 days after treatment. Unleaded motor gasoline produced dermal irritation (erythema and edema) to the skin of rabbits as a result of 24 -hour exposure. Erythema was fully reversible within 7 days and edema was fully reversible within 14 days.

The erythema and edema scores of unleaded motor gasoline (API PS-6) indicated a potential to cause dermal irritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure, occlusive wrap
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Gasoline
EC Number:
289-220-8
EC Name:
Gasoline
Cas Number:
86290-81-5
Constituent 2
Reference substance name:
unleaded gasoline
IUPAC Name:
unleaded gasoline
Test material form:
other: low viscosity liquid hydrocarbon

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: non-abraded and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
Observations were made and 24 and 72 hours and at 7 and 14 days after treatment.
Number of animals:
6 animals
Details on study design:
Observations were not made at 48 hours. Therefore, the mean erythema and mean edema scores do not reflect a 24, 48, and 72 hour average, rather they reflect a 24 and 72 hour average.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 72 hrs
Score:
ca. 0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not Specified
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24 hrs
Score:
ca. 0.5
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 72 hrs
Score:
ca. 0.5
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 7 days
Score:
ca. 0.92
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Remarks:
24/72 hr time point average
Time point:
other: 24/72 hr
Score:
ca. 0.5
Max. score:
0.5
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not Specified
Other effects:
Unleaded motor gasoline was administered via an occlusive dermal patch on abraded skin. The erythema scores at 24 and 72 hours and at 7 and 14 days were 0.0, 1.0, 0.17, and 0.0, respectively. Erythema was fully reversible within 14 days after treatment. The edema scores at 24 and 72 hours and at 7 and 14 days were 0.5, 0.5, 1.08, and 0.0, respectively. Edema was fully reversible within 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results of this study cannot be directly interpreted for classification of skin irritation due to deviations from the EEC regulatory protocol, consisting of the use of a 24 hr, rather than a 4 hr, exposure period and the use of an occlusive, rather than a semi-occlusive, wrap.
Executive summary:

Unleaded motor gasoline (API PS-6) was administered via occlusive dermal patch on non-abraded and abraded skin of 6 New Zealand White rabbits at doses of 0.5 ml for 24 hours to assess dermal irritation. Clinical observations were made at 24 and 72 hours and at 7 and 14 days after treatment. Unleaded motor gasoline produced dermal irritation (erythema and edema) to the skin of rabbits as a result of 24 -hour exposure. Erythema was fully reversible within 7 days and edema was fully reversible within 14 days.

The erythema and edema scores of unleaded motor gasoline (API PS-6) indicated a potential to cause dermal irritation.